Association Between Basal Proteinuria Levels and Pregnancy Outcomes in Familial Mediterranean Fever

Basal Proteinuria in Pregnancy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02092064
• Other study ID #: Basal Proteinuria in FMF
• Status: Not yet recruiting
• Phase: N/A
• First received: March 17, 2014
• Last updated: March 18, 2014
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: March 2014
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: cantekin iskender, md
• Phone: +90- 312-306-5000
• Email: c_iskender[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

to investigate the effect of basal proteinuria on pregnancy outcomes of patients with Familial Mediterranean fever (FMF).

Description:

Familial Mediterranean fever (FMF) is also known recurrent polyserositis the most common hereditary recurrent febrile disorder. It is characterized by paroxysmal episodes of the high fever and signs of serositis-peritonitis, pleuritis, synovitis. Between these attacks, patients are usually asymptomatic. FMF mainly affects populations of the Mediterranean region such as Turks.

The diagnosis of FMF may be extremely difficult to establish in the presence of atypical signs, and absence of family history . Colchicine is effective in most of the patients with FMF. The one the most important complications of FMF is the development of renal amyloidosis. It potentially progress sequentially through preclinical, proteinuric, nephrotic, azotemic and uremic stages to end stage renal disease if not treated properly with colchicine. Previous studies suggests that colchicine does not appear to be a major human teratogen, and, probably, has no cytogenetic effect.

FMF affects females mainly in their childbearing years. FMF is associated with higher rates of recurrent abortion, premature rupture of membranes (PROM) and preterm birth. Despite of adverse outcomes have been reported in pregnants with FMF the outcome of pregnancies in FMF appear favorable with the healthy population since the usingof the colchicine. Although the effect of pregnancy on the course of FMF related amyloidosis is controversial, it is generally accepted that renal function may disrupt during pregnancy.

Few studies have investigated the effect of FMF complications (amyloidosis and nephrotic syndrome) on pregnancy course.

The aim of this study is to investigate the effect of basal proteinuria on pregnancy outcome of patients with Familial Mediterranean fever (FMF).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• pregnant patients with FMF

Exclusion Criteria:

• multiple pregnancies

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Basal Proteinuria in Pregnancy
• Familial Mediterranean Fever
• Hereditary Autoinflammatory Diseases
• Proteinuria

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Turgal M, Selcuk I, Ozyuncu O. Pregnancy outcome of five patients with renal amyloidosis regarding familial Mediterranean fever. Ren Fail. 2014 Mar;36(2):306-8. doi: 10.3109/0886022X.2013.846863. Epub 2013 Oct 29. — View Citation

Yasar O, Iskender C, Kaymak O, Taflan Yaman S, Uygur D, Danisman N. Retrospective evaluation of pregnancy outcomes in women with familial Mediterranean fever. J Matern Fetal Neonatal Med. 2014 May;27(7):733-6. doi: 10.3109/14767058.2013.837446. Epub 2013 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in proteinuria correlation to the adverse outcomes of pregnancy		6 months	No